Fat-derived stem cells safe and feasible for SPMS, clinical trial

I have secondary progressive multiple sclerosis (SPMS) and am delighted with any advance in treating that form of the disease.

This week, I am pleased that a clinical trial shows that fat-derived stem cells are a safe and feasible treatment for people with SPMS.

The study, Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study, was published in the journal PLOS One.

This is encouraging because very few therapies have been developed for the secondary progressive type of MS but don’t get carried away. This trial was all about safety and feasibility. It did not seek to measure the effectiveness of fat-derived stem cells as a treatment.

Trials with animal models of MS have shown that stem cells can help repair the central nervous system. This means they could potentially some of the neurodegeneration that leads to SPMS.

It was thought that Adipose or fat–derived stem cells (AdMSCs) are beneficial because they can be acquired easily. It can be done via a minimally invasive procedure called a lipectomy, which is a surgical procedure to remove body fat.

Fat-derived stem cells harvested by lipectomy

Despite the theories, the use of AdMSCs had not been tested in patients with SPMS. That’s the reason that researchers set out to determine the safety and feasibility of treating SPMS patients with two different doses of AdMSCs in a Phase 1/2 clinical trial (NCT01056471).

Researchers reported that they first obtained the AdMSCs from consenting patients through a lipectomy.

Then, 30 of these patients randomly receive either a single infusion of placebo, low-dose AdMSCs (1×106cells/kg), or high-dose ADMSCs (4×106cells/kg), and were then followed for 12 months. In total, 11 patients were given placebo, 10 were given low-dose, and nine were given high-dose AdMSCs.

During the treatment, only one adverse event was observed in the AdMSC treatment group, and that was not considered to be related to the treatment. The one event was a patient developed a urinary infection but there were no other safety issues.

Researchers concluded: “Although the study was not powered to determine the efficacy, some hint of efficacy was observed by the use of MRI and evoked potentials.

“Larger studies would be needed to investigate the potential therapeutic benefit of the technique.”

I shall certainly be watching future developments with interest, particularly as I was not able to proceed with hematopotetic stem cell transplantation (HSCT).

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor, so cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Stem cell treatment helps people with MS, Phase 1 clinical trial

Stem cell treatment improved neurological symptoms of 75% of people with multiple sclerosis in a Phase 1 clinical trial, say researchers in the USA.

Results were so encouraging that they prompted the team, at Tisch MS Research Center of New York, to start a Phase 2 trial. This is to allow them to assess further the safety and effectiveness of the therapy.

I must say that it is important to remember that this stem cell treatment is NOT HSCT. Importantly, the treatment being trialed does not involve suppressing and rebuilding the autoimmune system. Instead, this trial involves injecting mesenchymal stem cell-derived nerve cell progenitors directly into the spinal canal.

The study, “Phase I Trial of Intrathecal Mesenchymal Stem Cell-Derived Neural Progenitors in Progressive Multiple Sclerosis,” was published in the journal EBioMedicine.

In the open-label trial (NCT01933802):

  • 80% of patients had secondary progressive MS (SPMS);
  • Half were unable to walk at the beginning of the study. They had Expanded Disability Status Scale (EDSS) scores of 7 or higher;
  • Eight required assistance to walk. They had EDSS scores of 6 to 6.5;
  • Two were able to walk without assistance. They EDSS scores between 3.5 and 5.5.

Stem cell treatment led to improvements in neurological symptoms of 75% of the patients. The condition of 10% worsened, 15% remained the same.

Interestingly, 70% of the patients had better muscle strength after the treatment, mainly in the lower limbs.

Of those who were able to walk when the trial began, 40% improved their scores on a measure of exercise capacity — the timed 25-foot walk test — by at least 20%. Additionally, those who couldn’t walk at the start were later able to complete the walk test with assistive devices.

Disability scores improved

Researchers say that those who responded to the treatment improved their disability scores by 0.5 to 2.0 EDSS points.

Other key points of the trial were:

  • The stem cell treatment improved the bladder function of half the patients with a problem. Some were able to stop taking their bladder medications.
  • There were no serious adverse effects associated with the therapy. About 85% of the patients experienced headaches and fever in the first 24 hours after the treatment. Doctors managed these with standard medications.
  • The treatment consisted of three injections of stem cells derived from the patients, administered three months apart. Patients received antibiotics to reduce the risk of infection.

Dr Violaine Harris.

Researchers used fresh cells, rather than cells preserved by refrigeration, and say this may have contributed to the good results.

Senior research scientist at the Tisch center, Dr Violaine Harris said: “The protocol we created allowed for delivery of these stem cells within 30 minutes of harvesting” them.

Dr Saud A Sadiq.

Tisch center’s director and senior author of the study, Dr Saud A Sadiq added that the Phase 1 results “justify the initiation of a planned FDA-approved Phase 2 trial in a larger group of patients.

“We anticipate that these novel studies may form the therapeutic basis of reversing disability in patients with MS, and if successful, these studies could have positive implications for treating other neurological diseases,” he said.

Researchers are now seeking to recruit about 50 patients with primary progressive or secondary progressive MS for the Phase 2 trial (NCT03355365). Patients must have an EDSS between 3 and 6.5. For additional information, click here.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Frankincense – a possible future treatment for MS, new research

One of the original Christmas presents may turn out to be a 21st century gift to people with multiple sclerosis.

Most people, whatever their faith if any, will be familiar with the story of the Three Kings, or wise men. According to the story, they arrived in Bethlehem and gave the baby Jesus their offerings of gold, frankincense and myrrh.

If you didn’t know, and I don’t see why you should, frankincense is an aromatic resin used in incense and perfumes. It is obtained from trees of the genus Boswellia.

frankincense

The tree from which frankincense is obtained.

Now, a group of researchers in Germany say that an extract can be used to treat relapsing MS.

The study, “A standardised frankincense extract reduces disease activity in relapsing-remitting multiple sclerosis (the SABA phase IIa trial)” was published in the Journal of Neurology, Neurosurgy, and Psychiatry, on December 16, 2017.

It found that an oral administration of a standardised frankincense extract (SFE) is safe and reduces disease activity in patients with relapsing multiple sclerosis (RMS).

The researchers concluded that the oral SFE was safe, tolerated well and exhibited beneficial effects on RMS disease activity. They added that it warrants further investigation in a controlled phase IIb or III clinical trial.

Frankincense study explained

The study reports that, after a 4-month baseline observation phase, patients were treated for 8 months with an option to extend treatment for up to 36 months.

It says: “The primary outcome measures were the number and volume of contrast-enhancing lesions (CEL) measured in MRI during the 4-month treatment period compared with the 4-month baseline period.

“Eighty patients were screened at two centres, 38 patients were included in the trial, 28 completed the 8-month treatment period and 18 of these participated in the extension period.

“The SFE significantly reduced the median number of monthly CELs from 1.00 to 0.50 at months 5-8. We observed significantly less brain atrophy as assessed by parenchymal brain volume change.

“Adverse events were generally mild (57.7%) or moderate (38.6%) and comprised mainly gastrointestinal symptoms and minor infections.  

“Mechanistic studies showed a significant increase in regulatory CD4+ T cell markers and a significant decrease in interleukin-17A-producing CD8+ T cells, indicating a distinct mechanism of action of the study drug.”

The science seems to be based on the fact that frankincense contains boswellic acids that are anti-inflammatory.

It will be interesting to see if further studies will be undertaken and, if so, what the eventual outcome may be.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

* * * * *

50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is intended for your general knowledge only and is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

CCSVI treatment does NOT work for MS, says clinical trial

At last, researchers have found the truth about using angioplasty to treat CCSVI in people with multiple sclerosis. They have found it is not effective and say it is not recommended.

The research team included Dr Paolo Zambini, the doctor who first proposed there was a link but now accepts that he was mistaken.

CCSVI, or chronic cerebrospinal venous insufficiency to give its full name, is characterized by restricted venous outflow from the brain and spinal cord. Its treatment, by venous percutaneous transluminal angioplasty (PTA). This uses balloons to enlarge veins so that more blood flows out of the brain and spinal cord, and so restore normal blood flow.

However, it has been controversial on two fronts. The first is whether CCSVI is associated with MS. And, second, whether its treatment by PTA is beneficial in people with MS.

Researchers in Italy have conducted a clinical trial, and its report states that the PTA procedure did NOT improve the participants’ functioning or reduce their brain lesions.

In conclusion, researchers said that venous PTA cannot be recommended in patients with MS. It has proven to be largely ineffective technique, although safe.

CCSVI trial explained

ccvsiResearchers published their study in the journal JAMA Neurology. The title is “Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis A Randomized Clinical Trial.

The objective of the trial was to determine the efficacy and safety of venous PTA in patients with MS and CCSVI.

The Brave Dreams trial was a multicentre, randomized, double-blind, sham-controlled, parallel-group trial to evaluate the efficacy and safety of venous PTA in patients with MS and CCSVI in extracranial or extravertebral veins.

It analyzed 177 patients with relapsing-remitting MS; 62 were ineligible, including 47 (26.6%) who did not have CCSVI on colour Doppler ultrasonography screening. A total of 115 patients were recruited in the study timeframe. All patients underwent a randomized, double-blind, sham-controlled, parallel-group trial in six MS centres in Italy. The trial began in August 2012 and concluded in March 2016; data was analyzed from April 2016 to September 2016.

Patients were randomly allocated (2:1) to either venous PTA or catheter venography without venous angioplasty (sham).

An end to the CCSVI controversy?

Dr Paolo Zamboni.

Controversy has raged since 2009, when Zamboni, from the University of Ferrara in Italy, put forward the idea that CCSVI may contribute to nervous system damage in MS. He also published results from a study which demonstrated that CCSVI was present in all the individuals with MS who he examined.

In truth, however, not everyone with MS has CCSVI. Further, although considered a safe procedure, the angioplasty treatment does not help with MS symptoms. This well-regulated double-blind clinical trial says so – and so, now, does Dr Zamboni.

As far as I am concerned, this puts the whole issue of CCSVI treatment for MS to rest. But I am sure some diehards will attempt to keep the controversy going.

I have always been highly skeptical of claims that the treatment could help relieve MS symptoms. This trial proves the claims to be wrong. Zamboni admits he was wrong. Enough said.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

* * * * *

50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

* * * * *

Note: Health-related information available on 50shadesofsun website is intended for your general knowledge only and is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

 

Stem cell trial patients are leading a normal life

This is my column, today, in MS News Today. I thought you’d like to know about it:

Stem Cell MS Patients Lead Normal Life Thanks To aHSCT Procedure

People with MS who were involved in a long-term clinical trial are out and about enjoying a full and normal life with no signs of the disease. This follows their recovery from the stem cell transplants involving aggressive chemotherapy, or aHSCT as the procedure is known.

Results of the clinical study reached major news sources, including Multiple Sclerosis News Today on Friday after first being unveiled in The Lancet.

The 24 multiple sclerosis patients recruited for the trial were severely disabled but, with the exception of one who died, are now walking, working, kayaking, and skiing.

The trial is the first in the world to show complete long-term stopping of relapses of the debilitating disease and …

 

read more here: stem-cell-ms-patients-lead-normal-life

 

 

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Stem cell clinical trial is real, not ‘false hope’

stem cell therapy_edited

This blog’s story about the outcome of the long-term clinical trial of stem cell therapy was deleted from one Facebook group on the grounds that it did not wish to allow anything that would give its members ‘false hope’.

Actually, nor do I.

That is why, writing both in Multiple Sclerosis News Today and here, I very carefully kept to the findings as published in The Lancet, plus comments made afterwards.

The fact is that this was the first long-term clinical trial of the same procedure as used today in major HSCT clinics worldwide. It was a small trial but that was acknowledged by the researchers who said a larger trial was necessary.

I purposely did not say, as many journalists did, that scientists are close to finding a cure. Theaustralian.com.au said ‘Multiple Sclerosis cure very near’ while thetimes.co.uk said ‘Scientists close to a cure for multiple sclerosis’. That was not a statement made in the study’s report, nor was it claimed afterwards. I can see little justification for headlines mentioning a ‘cure’. Just one doctor, a stem cell biologist not involved in the trial described it as ‘close to being curative’.

HSCT or, more correctly, aHSCT has never been claimed to be a cure. Despite some notable anecdotal tales of the disease being reversed in some people, the therapy has only ever been claimed to stop MS progressing; to stop it getting worse.

And that is what the clinical trial proved. It said relapses were halted and MRI scans showed no new brain lesions.

The word ‘cure’ was not mentioned in the report of the trial, nor in my story about it.  So, no false hope there!

It is a shame that members of one FB group were denied the opportunity of seeing my fair and objective article on this issue.

Now, if I had wanted to court controversy or talk about ‘false hope’, I could have written about CCVI and its supposed link with MS, which is unsupported scientifically. The whole issue of CCVI still divides opinion and is, at best, unproved by any clinical trial that meets accepted standards. That may change in the future. Who knows?

 

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Long-term clinical trial Proves stem cell therapy that destroys immune system Does Stop MS

As regular readers of this blog will know, I also now write a column for MS News Today but, yesterday, I was asked to write a news story. You might be interested:

Aggressive Stem Cell Therapy Stops MS Relapses, According to Long-term Clinical Trial

JUNE 10, 2016  BY IAN FRANKS

Stem cell treatment has been proven to both halt MS clinical relapses and the development of new brain lesions over a prolonged period, according to the results of a new study.

The results, achieved in 23 out of 24 patients in a Phase 2 clinical trial, were published in The Lancet in an article titled “Immunoablation and autologous haemopoietic stem-cell transplantation for aggressive multiple sclerosis: a multicentre single-group Phase 2 trial.”

Importantly, the success was reached without the need for ongoing medication.

It is the first time that results of this form of autologous haematopoietic stem cell transplantation (aHSCT) have been trialed — using chemotherapy to completely destroy a patient’s immune system and then transplant previously harvested stem cells to reset or reboot the immune system to stop it harming the body. It is the method used in several leading clinics, including those in Russia and Mexico.

Some other centers, however, only go as far as suppressing, not destroying, the immune system. According to a recent press release, the suppression method is not as reliable, with many patients finding that …

 

To read the whole story, please follow this link: multiplesclerosisnewstoday.com stem-cell-transplants-stop-ms-long-term-clinical-trial

 

 

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